Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05722548

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Condition or Disease	Intervention/Treatment	Phase
Pancreatectomy	Drug: Indomethacin suppository Other: Standard Medical Treatment	Phase 2

Detailed Description

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment	Drug: Indomethacin suppository 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia Other: Standard Medical Treatment Standard Medical Treatment
Active Comparator: Group B Standard Medical Treatment	Other: Standard Medical Treatment Standard Medical Treatment

Arm

Intervention/Treatment

Experimental: Group A

Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Drug: Indomethacin suppository

100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia

Other: Standard Medical Treatment

Standard Medical Treatment

Active Comparator: Group B

Standard Medical Treatment

Other: Standard Medical Treatment

Standard Medical Treatment

Outcome Measures

Primary Outcome Measures

Post-pancreatectomy Acute Pancreatitis [2 weeks after pancreatectomy]

Secondary Outcome Measures

Pancreatic Fistula [30 days after pancreatectomy]
Peripancreatic abscess [30 days after pancreatectomy]
Length of hospital stay [30 days after pancreatectomy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

*All patients planned to undergo pancreatectomy.

Exclusion Criteria:

asthma
allergic reactions to NSAIDs
CKD
internal hemorrhoids
anti-platelet medications

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator: Yingbin Liu, PHD, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yingbin Liu, MD, PhD, FACS, prof., Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT05722548

Other Study ID Numbers:

LYBWWG2023

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatitis

Indomethacin

Study Results

No Results Posted as of Feb 10, 2023